(71 days)
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No
The summary describes a semi-automatic urinalysis instrument that reads reagent strips, with no mention of AI, ML, or advanced image processing techniques typically associated with such technologies.
No
The device is described as an "in vitro diagnostic aid" and is used for analyzing urine, which is for diagnostic purposes, not therapeutic intervention.
Yes
The UriMate Reagent Strips, which are read by the Stripmax 1210 Urine Chemistry Analyzer, are explicitly stated to be "intended for use as an in vitro diagnostic aid."
No
The device description explicitly states it is a "semi-automatic urinalysis instrument," indicating it is a hardware device that reads reagent strips.
Yes, based on the provided text, the Stripmax 1210 Urine Chemistry Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The text explicitly states that the UriMate Reagent Strips, which the analyzer reads, are "intended for use as an in vitro diagnostic aid using urine specimens." Since the analyzer is designed specifically to read these IVD strips, it is also considered an IVD device as it is part of the diagnostic system.
- Device Description: The description reiterates that the UriMate Reagent Strips are "intended for use as an in vitro diagnostic aid."
The core function of the system (analyzer + strips) is to perform diagnostic tests on biological samples (urine) outside of the body (in vitro), which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis.
UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.
Product codes
KQO, JIL, JIO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
BioCare Corporation c/o Mr. Bruce A. McFarland Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439
NOV 0 2 2001
Re: K012829 Trade/Device Name: Stripmax 1210 Urine Chemistry Analyzer; Urimate Reagent Strip for Urinalysis Regulation Number: 21 CFR 862.2900; 21 CFR 862.1340; 21 CFR 864.6550 Regulation Name: Automated Urinalysis System; Urinary glucose (nonquantitative) test system: Occult blood test Regulatory Class: Class I; Class II; Class II Product Code: KQO, JIL, JIO Dated: August 15, 2001 Received: August 23, 2001
Dear Mr. McFarland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Drivinessification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire specific acvices), please contact devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 594-1500. I reading at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsion and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
NOV 0 2 2001
Indications for Use
510(k) Number:
Device Name: Stripmax 1210 Urine Chemistry Analyzer and UriMate Reagent Strip for Urinalysis
Indications for Use:
The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis.
UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Licen Cooser
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012829